SFAM SFAM801

GUDID 00850987007598

"SFAM801 8mm ePTFE Block - 5cm X 6cm"

SURGICAL TECHNOLOGY LABORATORIES INC

PTFE/carbon-fibre craniofacial tissue reconstructive material

• Primary Device ID: 00850987007598
• NIH Device Record Key: 54ca65f7-68b6-4108-9e7f-edc9735d0a82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFAM
• Version Model Number: SFAM801
• Catalog Number: SFAM801
• Company DUNS: 080380106
• Company Name: SURGICAL TECHNOLOGY LABORATORIES INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850987007598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021889

FDA Product Code

• KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [SFAM]

• 00085198807990: SFAM ePTFE Block 10cm X 6cm
• 00854804007037: SFAM503 ePTFE Block - 1.5cm x 6cm
• 00854804007020: SFAM1003 ePTFE Block 1.5cm x 6cm
• 00854804007013: SFAM803 ePTFE Block 1.5cm X 6cm
• 00854804007006: SFAM603 ePTFE Block 1.5cm x 6cm
• 00850987007604: "SFAM802 8mm ePTFE Block - 6cm X 10cm"
• 00850987007598: "SFAM801 8mm ePTFE Block - 5cm X 6cm"
• 00850987007581: "SFAM800 A/B 8mm ePTFE Block - 3cm X 7cm"
• 00850987007574: SFAM800 8mm ePTFE Block - 3cm X 7cm
• 00850987007567: "SFAM601 6mm ePTFE Block - 5cm X 6cm"
• 00850987007550: "SFAM600 6mm ePTFE Block - 3cm X 6cm"
• 00850987007543: "SFAM502 5mm ePTFE Block Bulk- 6cm x 10cm"
• 00850987007536: "SFAM501 5mm ePTFE Block - 5cm X 7cm"
• 00850987007529: "SFAM500 5mm ePTFE Block - 3cm X 7cm"
• 00850987007512: "SFAM302 3mm ePFTE (20-40 micron) - 7 cm x 7cm"
• 00850987007505: "SFAM301 3mm ePFTE (20-40 micron) - 3 cm x 7cm"
• 00850987007499: "SFAM201 2mm ePFTE (20-40 micron) - 7 cm x 7cm"
• 00850987007482: "SFAM200 2mm ePFTE (20-40 micron) - 3 cm x 7cm"
• 00850987007475: "SFAM101 1mm ePFTE (20-40 micron) - 7 cm x 7cm"
• 00850987007468: "SFAM1002 10mm ePTFE Block - 6cm X 10cm"
• 00850987007451: "SFAM1001 10mm ePTFE Block - 6cm X 5cm"
• 00850987007444: "SFAM1000 10mm ePTFE Block - 3cm X 6cm"
• 00850987007437: "SFAM100 1mm ePFTE (20-40 micron) - 3 cm x 7cm"
• 00850987007420: "SFAM035C ePTFE Contoured Sheet (0.35mm)"
• 00850987007413: "SFAM035 ePTFE Flat Sheet (0.35mm)"
• 00850987007406: "SFAM 500 A/B 5mm ePTFE Block - 3cm X 7cm"
• 00850987007390: "ESH-773 3mm ePTFE Sheet (7x7cm)"
• 00850987007383: "ESH-772 2mme PTFE Sheet (7x7cm)"
• 00850987007376: "ESH-771 1mm ePTFE Sheet (7x7cm)"
• 00850987007369: "ESH-7143 3mm ePTFE Sheet (7x14cm)"
• 00850987007352: "ESH-7142 2mm ePTFE Sheet (7x14cm)"
• 00850987007345: "ESH-7141 1mm ePTFE Sheet (7x14cm)"
• 00850987007338: "ESH-373 3mm ePTFE Sheet (3x7cm)"
• 00850987007321: "ESH-372 2mm ePTFE Sheet (3x7cm)"
• 00850987007314: "ESH-371 1mm ePTFE Sheet (3x7cm)"
• 00851988007990: SFAM ePTFE Block 10cm X 6cm
• 00854804007051: 6mm ePTFE Block - 1.5cm x 6.2cm